Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

Phase 2

• Conditions: Oral Mucositis; Head and Neck Cancer
• Interventions: Drug: Zi-Yin-Liang-Ge-San

• Registration Number: NCT05040425
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.

Detailed Description

200 head and neck cancer patients who were scheduled for radiotherapy are randomly assigned at a 1:1 ratio to two arms: control group and those treated with Zi-Yin-Liang-Ge-San containing Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis from day 1 of radiotherapy. The study lasted at least 6 weeks and the clinical benefit was determined by onset, gradation of mucositis (Common Terminology Criteria for Adverse Events v5.0), oral pain (visual analysis scale) for each week during RT. Nutritional status, EORTC Quality of Life Core Questionnaire (QLQ-C30) and head and neck module (QLQ-H\&N35), Body Constitution Questionnaire (BCQ), and electrical body conductivity were evaluated before and after radiotherapy. Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE), serious adverse events, blood and biochemical analysis will be recorded to evaluate the safety.

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08-30
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Study First Posted: 2021-09-10
• Last Update Posted: 2021-09-10
• Primary Completion: 2022-08-17
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Histologically proven stage II-IV squamous HNC
• Indication for radiotherapy or radio-chemotherapy
• No history of antitumor therapies
• No history of oral ulcer and salivary gland diseases
• Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria

• Terminal cancer for which aggressive treatments were not suitable
• Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit)
• Uncontrolled psychiatric problems or altered mental status
• Had received medications for other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese herbal medicine treatment	Zi-Yin-Liang-Ge-San	-

Primary Outcome Measures

Name	Time	Method
Degree of oral mucositis	During the radiotherapy course, up to 6 weeks	The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Mucositis pain	During the radiotherapy course, up to 6 weeks	100-mm-visual analog scale (VAS, 0-100)

Secondary Outcome Measures

Name	Time	Method
Body mass index (BMI)	During the radiotherapy course, up to 6 weeks	Body mass index (BMI)
Health related-QoL (1)	Baseline, 4th week, and 6th week of radiotherapy completion	EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)
Health related-QoL (2)	Baseline, 4th week, and 6th week of radiotherapy completion	Quality of Life Head and Neck Module (QLQ-H\&N35)